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Device
CPAP Therapy for Sleep Apnea
N/A
Recruiting
Led By Ali Azarbarzin, PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults aged 21-80 years
Be older than 18 years old
Must not have
Use of medications that might depress respiration (including opioids, barbiturates, benzodiazepines, and Z drugs, including zolpidem, zopiclone, eszopiclone, and zaleplon)
Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea: central sleep apnea (>50% of respiratory events scored as central), chronic hypoventilation/hypoxemia (awake SaO2 < 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Summary
This trial is studying whether or not CPAP can help people with obstructive sleep apnea (OSA) by better characterizing OSA-related physiological consequences during sleep.
Who is the study for?
Adults aged 21-80 with moderate to severe obstructive sleep apnea (OSA) and an apnea-hypopnea index over 15 events/hr are eligible. They must not be currently treated for OSA, have uncontrolled medical issues, heart failure, renal insufficiency, neurological conditions affecting respiration, or use respiratory-depressing meds. Pregnant women and those with other sleep disorders or active non-prescription opioid use are excluded.
What is being tested?
The trial is testing the effectiveness of Continuous Positive Airway Pressure (CPAP) in treating OSA by using new metrics to assess hypoxemia ('hypoxic burden'), autonomic response ('heart rate burden'), and sleep fragmentation ('arousal burden') rather than just the apnea-hypopnea index.
What are the potential side effects?
While CPAP is generally safe, potential side effects include discomfort or irritation from the mask interface, dry nose or throat, nasal congestion, headaches, bloating and difficulty tolerating forced air.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 80 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking medications that can slow my breathing.
Select...
I have a sleep or breathing disorder other than obstructive sleep apnea.
Select...
I have a history of heart failure, kidney issues, or neurological conditions affecting my breathing.
Select...
I cannot or do not want to use CPAP.
Select...
I have a diagnosed sleep disorder like narcolepsy or frequent limb movements.
Select...
I often can't sleep for more than 6 hours a night.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline 24-hour mean systolic blood pressure at 12 weeks
Change from baseline Epworth Sleepiness Scale (ESS) at 12 weeks
Change from baseline flow-mediated vasodilation at 12 weeks
Secondary study objectives
Change from baseline 24-hour mean blood pressure at 12 weeks
Change from baseline 24-hour mean diastolic blood pressure at 12 weeks
Change from baseline Albumin without Creatinine at 12 weeks
+19 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Positive Airway Pressure DeviceExperimental Treatment1 Intervention
All participants will receive PAP therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PAP
2016
N/A
~90
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,653 Previous Clinical Trials
11,490,877 Total Patients Enrolled
12 Trials studying Sleep Apnea
6,702 Patients Enrolled for Sleep Apnea
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,049 Total Patients Enrolled
15 Trials studying Sleep Apnea
5,400 Patients Enrolled for Sleep Apnea
Ali Azarbarzin, PhDPrincipal Investigator - Brigham and Women's Hospital
Brigham and Women's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with moderate to severe obstructive sleep apnea.I am between 21 and 80 years old.I am currently taking medications that can slow my breathing.I have a sleep or breathing disorder other than obstructive sleep apnea.I have a history of heart failure, kidney issues, or neurological conditions affecting my breathing.I do not have any major health issues that could affect the study's evaluation.You have more than 15 pauses in breathing while sleeping.I cannot or do not want to use CPAP.I have not started treatment for sleep apnea before my first visit.I have a diagnosed sleep disorder like narcolepsy or frequent limb movements.I often can't sleep for more than 6 hours a night.You are currently using illegal drugs like cocaine or methamphetamine.
Research Study Groups:
This trial has the following groups:- Group 1: Positive Airway Pressure Device
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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